510(k) · Cleared
ClearedLife Spine Laminoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Oct 12, 2018 as substantially equivalent to K050082 (Medtronic Sofamor Danek, Inc., 2005) and 2 other predicates after a 106-day review. Its family tree reaches back 4 generations to 1976. 1 later device descends from it.
- Decided
- Oct 12, 2018
- Review
- 106 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K761228 (1976). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 3 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 2 generations backK032534 Synthes AfsSynthes Spine · 2004
- 1 generation backK113802 Escalate Laminoplasty SystemStryker Spine · 2012
- This deviceK181717 Life Spine Laminoplasty SystemLife Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK191927 Hinged Laminoplasty SystemLife Spine, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191927Hinged Laminoplasty SystemLife Spine, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −3 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| −1 | K113802 | Escalate Laminoplasty System | Stryker Spine | 2012 | — |
| 0 (this device) | K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | 2018 | — |
| +1 | K191927 | Hinged Laminoplasty System | Life Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQW device
- #1 K243137 Curiteva Porous PEEK Laminoplasty Systemscore 13.1 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050082 | Centerpiece Plate Fixation SystemSummary page 4…n Name: Spinal Interlaminal Fixation Orthosis Classification: NQW, CFR 888.3050, Class II Primary Predicate: Medtronic Centerpiece (K050082) Secondary Predicate: Stryker Escalate (K113802) Synthes Arch (K032534) Device Descriptio… | 2005 |
| * | K113802 | Escalate Laminoplasty SystemSummary page 4…osis Classification: NQW, CFR 888.3050, Class II Primary Predicate: Medtronic Centerpiece (K050082) Secondary Predicate: Stryker Escalate (K113802) Synthes Arch (K032534) Device Description: The Life Spine Laminoplasty System consists of plate… | 2012 |
| * | K032534 | Synthes AfsSummary page 4…, Class II Primary Predicate: Medtronic Centerpiece (K050082) Secondary Predicate: Stryker Escalate (K113802) Synthes Arch (K032534) Device Description: The Life Spine Laminoplasty System consists of plates screws and screws in various diameters and length… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191927 | Hinged Laminoplasty System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 5 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K191927 (Life Spine, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K050082.
How does its category compare?
All NQW devicesNQW Orthosis, Spine, Plate, Laminoplasty, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NQW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQW
84in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQW
No recall names NQW since 2007.
Adverse event reports per year · NQW
33in 2025
MAUDE reports naming product code NQW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 3 | 120 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 120 | 0 | 1 |
| 2013 | 3 | 84 | 0 | 49 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 2 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Life Spine Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Laminoplasty System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181717 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181717: Life Spine Laminoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181717
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026